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FDA ANDA · ANDA208334

RIVAROXABAN

Sponsor: MICRO LABS

APPLICATION
ANDA208334
TYPE
ANDA
ORIGINAL APPROVAL
2026-06-30
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

RIVAROXABANPrescription
RIVAROXABAN 15MG · TABLET · ORAL
RIVAROXABANPrescription
RIVAROXABAN 2.5MG · TABLET · ORAL
RIVAROXABANPrescription
RIVAROXABAN 20MG · TABLET · ORAL
RIVAROXABANPrescription
RIVAROXABAN 10MG · TABLET · ORAL

Approval history

2026-06-30UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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